MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR071002J

Device Problem Partial Blockage (1065)

Patient Problems Stenosis (2263); Pseudoaneurysm (2605)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

The following publication was reviewed: two cases of viabahn implantation for the subclavian arterial injury.This patient is a man in his forties.On an unknown date, the patient fall during snowboarding.Three days later, swelling and pain in the right shoulder got worse, and the patient was referred to the hospital.Computed tomography angiography (cta) was performed, and pseudoaneurysm and arteriovenous fistula in the distal portion of the right subclavian artery was suspected.The patient was in poor general condition due to bleeding, and it was elected to utilize gore® viabahn® endoprosthesis with heparin bioactive surface.A micro guidewire was inserted from the right upper arm and a snare system was inserted from the right common iliac artery to apply pull-through technique.The endoprosthesis was implanted in the right subclavian artery with no reported issue.Three days after the procedure, cta confirmed that the pseudoaneurysm and the arteriovenous fistula disappeared.The patient discharged from the hospital seven days after the procedure.Four months after the procedure, ct showed a middle stenosis around proximal portion of the endoprosthesis and mild stenosis located distal to the first stenosis region.However, contrast effect remained in its distal area.No further issue was reported.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick la fave ; 9285263030
• MDR Report Key: 9226515
• MDR Text Key: 163954927
• Report Number: 2017233-2019-01082
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR071002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR